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FDA 510(k)

HYDROCOLLOID HEATING UNIT

K-Number: K935151 · 1994-04-04

ApplicantCentrix, Inc.
Decision Date1994-04-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROCOLLOID HEATING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 1994-04-04 under 510(k) number K935151. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROCOLLOID HEATING UNIT?

HYDROCOLLOID HEATING UNIT is a medical device that received FDA 510(k) clearance on 1994-04-04. The listed applicant is Centrix, Inc.. The 510(k) number is K935151.

When did HYDROCOLLOID HEATING UNIT receive FDA 510(k) clearance?

HYDROCOLLOID HEATING UNIT received FDA 510(k) clearance on 1994-04-04, under 510(k) number K935151.

Who is the listed applicant for HYDROCOLLOID HEATING UNIT?

The FDA 510(k) record lists Centrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROCOLLOID HEATING UNIT?

The FDA product code for HYDROCOLLOID HEATING UNIT is ELW.

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Other records listing Centrix, Inc. as applicant

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Related Devices (Code: ELW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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